LIMS Administrator

Harba; Indianapolis (IN); On-site; USD 90,000 - 130,000; Full time

Job summary

Harba is seeking an experienced LIMS Support Specialist to administer and optimize the laboratory information management system in a regulated environment. You will configure workflows, manage user access, and ensure data integrity across QC, QA, and R&D teams.

The role covers validation activities (IQ/OQ/PQ), instrument integration, regulatory inspections support, and documentation. Collaboration with IT, Validation, and Quality teams is essential to minimize downtime while maintaining

Qualifications

• Bachelor's degree in IT, Chemistry, Biology, Engineering, or related field.
• 3+ years administering or supporting a LIMS platform in regulated environments.
• Strong knowledge of cGMP, FDA regulations, 21 CFR Part 11, and data integrity (ALCOA+).
• Experience with LIMS validation activities (IQ/OQ/PQ).
• Familiarity with instrument integrations and workflows.
• Experience supporting FDA/regulatory inspections as a LIMS SME.
• Proficiency with MS Office; SQL knowledge is a plus.

Responsibilities

• Administer, configure, and maintain LIMS, including access, workflows, test methods, specs, and instrument integrations.
• Support day-to-day LIMS operations and troubleshoot user issues.
• Lead or support validation activities (IQ/OQ/PQ) for implementations, upgrades, and configuration changes.
• Manage LIMS user access controls and 21 CFR Part 11 compliance.
• Support integration of LIMS with instruments, ERP, MES, and other systems.
• Author and maintain LIMS configuration docs, SOPs, and change records.
• Investigate deviations, data discrepancies, or downtime.
• Serve as LIMS SME during audits and inspections (FDA, ISO).
• Coordinate system upgrades, patches with minimal disruption.
• Collaborate with QC/QA/R&D to translate requirements into LIMS configuration.
• Support end-user training on LIMS features and best practices.
• Ensure design/configuration/docs comply with FDA, cGMP, 21 CFR Part 11, ALCOA+.

Skills

LIMS administration

FDA/regulatory familiarity

cGMP knowledge

SQL knowledge

Cross-functional collaboration

Documentation

Education

Bachelor's degree in IT/Chemistry/Biology/Engineering

Tools

LabWare

LabVantage

STARLIMS

Thermo SampleManager

Job description

Responsibilities

• Administer, configure, and maintain the LIMS platform, including user access, workflows, test methods, specifications, and instrument integrations
• Support day-to-day LIMS operations, including troubleshooting user issues, resolving system errors, and coordinating with IT/vendor support as needed
• Lead or support validation and qualification (IQ/OQ/PQ) activities for LIMS implementations, upgrades, and configuration changes in partnership with Validation and Quality teams
• Manage LIMS user access controls, roles, and permissions in compliance with data integrity and 21 CFR Part 11 requirements
• Support integration of LIMS with laboratory instruments, ERP, MES, and other quality/data systems
• Author and maintain LIMS configuration documentation, SOPs, and change control records
• Investigate and support root cause analysis for LIMS-related deviations, data discrepancies, or system downtime
• Serve as LIMS subject matter expert (SME) during internal audits and external regulatory inspections (FDA, ISO), including front room/back room support
• Coordinate LIMS system upgrades, patches, and periodic review activities, ensuring minimal disruption to lab operations
• Partner with QC, QA, and R&D lab personnel to translate testing and workflow requirements into LIMS configuration
• Support training of end users on LIMS functionality, new features, and best practices
• Ensure LIMS design, configuration, and documentation comply with FDA regulations, cGMP, 21 CFR Part 11, and internal data integrity standards (ALCOA+)
• Support risk assessments (FMEA) for LIMS changes, upgrades, or new instrument/method integrations
• Maintain accurate, audit-ready documentation for all LIMS validation, configuration, and change control activities

Qualifications

Required:

• Bachelor's degree in Information Technology, Chemistry, Biology, Engineering, or related field
• 3+ years of experience administering or supporting a LIMS platform (e.g., LabWare, LabVantage, STARLIMS, Thermo SampleManager, or similar) in a pharmaceutical, biotech, or medical device environment
• Strong working knowledge of cGMP, FDA regulations, 21 CFR Part 11, and data integrity principles (ALCOA+)
• Experience supporting or leading validation activities (IQ/OQ/PQ) for computerized laboratory systems
• Familiarity with laboratory instrument integration and workflows (e.g., HPLC, GC, dissolution testing)
• Experience supporting or leading FDA/regulatory inspections as a LIMS SME
• Proficiency with MS Office and database/reporting tools; SQL knowledge a plus
• Strong written and verbal communication skills, with ability to support both technical and non-technical stakeholders
• Ability to work effectively in a cross-functional, highly regulated laboratory environment